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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
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HOLOGIC, INC AFFIRM BREAST BIOPSY GUIDANCE SYSTEM Back to Search Results
Model Number STLC-00004
Medical Device Problem Code Imprecision (1307)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the affirm crashed during biopsy, after re-targeting more than 1 cm.No injury reported.A field engineer was dispatched to the site and determined the bcm, bgm pcb, and bgm cable needed to be replaced.Once this was completed the system was working as intended.
 
Additional Manufacturer Narrative
Correction to section b4.Date of this report.The year of the submission was incorrect and updated to december 31, 2019.
 
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Brand Name
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
Common Device Name
BIOPSY GUIDANCE SYSTEM
Manufacturer (Section D)
HOLOGIC, INC
36 & 37 apple ridge road
danbury CT 06810
MDR Report Key9612751
Report Number1220984-2020-00007
Device Sequence Number547766
Product Code IZH
UDI-Device Identifier15420045505858
UDI-Public(01)15420045505858
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K122836
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberSTLC-00004
Device Catalogue NumberSTLC-00004
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/31/2019
Supplement Date Received by Manufacturer12/31/2019
Initial Report FDA Received Date01/21/2020
Supplement Report FDA Received Date10/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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